Isotechnika Pharma Inc. (IPHAF/ISA.TO)Edmonton-based Isotechnika Pharma Inc. is a biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments. There is a significant unmet medical need in the treatment of both solid organ transplantation and autoimmune disease. It is estimated that the market potential will exceed $4 billion annually in sales for calcineurin inhibitors such as voclosporin by 2010.
Trading Catalyst
PDUFA: Aug. 3, 2010
Isotechnika's partner, Lux biosciences Inc., filed an NDA with the FDA back in February (accepted for review on Mar. 30) for vocloporin (porposed name: LUVENIQ). The drug is indicated for the treatment of non-infectious uveitis involving the posterior segment of the eye, a leading cause of vision loss and long-term disability and the fourth leading cause of legal blindness in the industrialized world. Voclosporin received a priority review status which shortens the review period to within six months from the standard 10-month review. A priority review designation is given by the FDA to drugs that are considered to have the potential to provide an important advancement in treatment or provide a treatment for which there is no adequate therapy available. The PDUFA action date for volcloporin is scheduled for Aug. 3, 2010
If the uveitis submissions are approved in the U.S. and Europe, Isotechnika will receive milestone payments of $7.04 million and $3.52 million, respectively, from Lux, as well as royalty payments on sales of the drug. Approval will also make the regulatory path easier in other indications with voclosporin because of the large amount of already submitted safety data.
Recent Development & Price Roller Coaster
The Dermatology and Ophthalmology Drugs Advisory Committee of the FDA was scheduled to review the NDA for voclosporin on June 28, 2010, sending the share price up ~56% during the last 3 weeks in anticipation of the review. Isotechnika, however, announced today that the FDA has canceled the advisory meeting, and this immediately caused the stock to tumble, shedding everything it accumulated before the news and falling back down to $0.24. So what does this mean? It means that there's an opportunity to ride the PDUFA wave - a significant push in share price as a result of heightened interest in the FDA's ruling on a NDA in a short period of time. Seeing the potential of hitting $0.44 (pre-announcement peak), buyers can expect the current beaten down price - $0.24 (due to FDA panel cancellation) to climb back up again in advance to the FDA's final decision on volclosporin approval on Aug. 3, 2010. Being merely 6 weeks away from the key catalyst date, now would be a suitable entry time.
About Voclosporin
Voclosporin is a next generation calcineurin inhibitor, which completed a Phase 2b North American trial for the prevention of kidney rejection following transplantation. Extensions to the Phase 2b trial and a combined Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis have also been completed. Isotechnika's partner, Lux BioSciences, Inc., has also completed three separate Phase 2/3 pivotal trials investigating voclosporin (referred to as LUVENIQ™ by Lux) for the treatment of uveitis. In addition to the uveitis trials, Lux BioSciences, Inc. has also commenced a Phase 1 trial using their proprietary voclosporin ophthalmic solution (LX214) as a candidate for dry eye syndrome.
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